In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The Renaissance study is a prospective, multi-center, single-arm study for use of the Express Renal
stent in the treatment of ostial atherosclerotic lesions of the renal artery Single, de novo or restenotic from prior PTRA lesions were to be included in the clinical trial. The primary objective of the study was to demonstrate a superior 9-month binary restenosis rate of the Express Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.
Study Population Description
The Boston Scientific Express SD Renal Monorail Premounted Stent System is indicated as an adjunct
to percutaneous transluminal renal angioplasty of a single de novo or restenotic atherosclerotic lesion (< 15 mm in length) of the renal artery, located within 5 mm of the opacified aortic lumen, with a reference vessel diameter of 4.0-7.0 mm to assist in the maintenance of vessel patency. The study population consists of the existing cohort of patients from the RENAISSANCE trial.
Sample Size
100 subjects with 117 lesions, the number of sites not reported
Data Collection
The primary endpoint is binary in-stent restenosis rate of the Express Renal Stent at nine
months, defined as the proportion of lesions with >50% diameter stenosis as determined by quantitative angiography.
Followup Visits and Length of Followup
All subjects will be evaluated at 30 days, 4 months, 9 months, and annually for
five years following the index procedure. The 30-day and 9-month visits must be office visits; the 4-month assessment is accomplished over the telephone. All subjects will undergo duplex ultrasound at 9 months and at 2 years after the index procedure. Office visits are required for the 1 -year and 2-year follow-ups. For the 3-, 4-, and 5-year annual follow-ups, office visits are strongly recommended; however, phone follow-ups at a minimum are required.
Final Study Results
Actual Number of Patients Enrolled
100 patients
Actual Number of Sites Enrolled
Not reported
Patient Followup Rate
82%
Final Safety Findings
No serious, device-related events that were unanticipated in nature, frequency or severity occurred during the
study. Furthermore, no new major adverse events occurred between the 4- and 5-year time points. Rates of target lesion revascularization, target vessel revascularization, and major adverse events have remained stable through 5 years of long-term follow-up with no unanticipated adverse device related events. No device- or procedure-related deaths or stent thromboses have been reported. No subjects progressed to require dialysis through 5 years of follow-up. The results from the study suggest that the Express SD Renal Stent System poses no serious concerns in terms of safety and effectiveness out to 5 year follow-up. As of October 23, 2009, no new revascularizations or significant embolic events have been reported between the 4-year and 5-year visits in any subject; 66 subjects completed the 5-year follow-up visit. Twenty-seven of 100 subjects (27%) had suffered a total of 49 reports of renal artery stenosis categorized as an SAE. The number of site-reported renal artery stenosis events requiring revascularization was 44; 26 of these 44 events in 16 subjects were adjudicated as target lesion revascularization. There have been a total of 19 reported deaths as of October 23, 2009. No deaths were adjudicated as either device- or index procedure-related. Based on the distribution of baseline co-morbidities, (e.g., congestive heart failure (CHF) rates, coronary artery disease (CAD) rates and the mean baseline age of the subjects enrolled in the RENAISSANCE study,) the sponsor concludes that the number of deaths through 5 years of follow-up is at an expected rate.
Study Strengths and Weaknesses
Strengths: Overall follow-up was 81.5% of eligible subjects returning for 5-year follow-up. Weaknesses: There was
no post approval hypotheses studied.
Recommendations for Labeling Changes
There were no recommendations for changes to the labeling based on the results of the
